Pfizer invests $120M in 4 biotechs through new growth fund

 Pfizer has made the first investments through its $500 million Pfizer Breakthrough Growth Initiative (PBGI). Homology Medicines received the biggest piece of the first tranche of PBGI funding, landing $60 million to support its work on treatments for rare genetic diseases. 

Pfizer established PBGI in June to provide support to public companies with small- to medium-sized market capitalizations and clinical-stage pipelines that map onto its own therapeutic areas of focus. Since then, Pfizer has invested $120 million in four biotechs, details of which were released by the company Tuesday.

News of three of the investments dripped out in a series of releases over the second half of 2020. The previously disclosed investments were in public companies. After tweaking its initial investment criteria to include some private companies, Pfizer was able to hold back news of one of the deals. 

Vedanta Biosciences scored the newly disclosed investment. Pfizer pumped $25 million into Vedanta to support a phase 2 clinical trial of a defined bacterial consortium, VE202, in inflammatory bowel disease (IBD) patients. Vedanta plans to start the study this year.

The phase 2 builds on an early-phase study that showed durable, dose-dependent colonization with the bacteria contained in VE202. Vedanta selected the bacteria to induce immune tolerance and, in doing so, treat IBD. Pfizer Senior Vice President Michael Vincent, M.D., Ph.D., will have a front-row view of Vedanta’s progress as part of the biotech’s scientific advisory board. 

Homology scooped half of the money invested by Pfizer in the first round of PBGI agreements. The biotech has a market capitalization of around $500 million and a pipeline led by a gene therapy that  is in phase 2 development in adults with phenylketonuria. Pfizer made the $60 million investment last year, extending Homology’s cash runway out to the third quarter of 2022 in the process.

Trillium Therapeutics also secured funding from Pfizer last year, receiving a $25 million investment to support clinical development of its CD47 program. The investment puts Pfizer in a strong position to pick up rights to assets in a field targeted by AbbVie and Gilead if Trillium gathers the data needed to land a deal.

ESSA Pharma received the smallest investment of the first round of PBGI deals, pocketing $10 million to support its work on prostate cancer therapies. Pfizer contributed to a $49 million public offering by ESSA last year. 

https://www.fiercebiotech.com/biotech/pfizer-invests-120m-4-biotechs-through-new-growth-fund

JPM: Teladoc to pilot CGMs in Type 2 diabetes, as Dexcom eyes new growth market

 Teladoc Health will launch a pilot demonstration of Dexcom’s wearable, continuous glucose monitoring systems in patients with Type 2 diabetes—picking up the torch from the devicemaker’s partnership with Livongo following its $18.5 billion acquisition last year.

The project will start by supplying the blood sugar sensors at no cost to certain members of Teladoc and Livongo’s diabetes program before expanding the pilot’s reach throughout the course of the year.

The goal is to improve outcomes and healthy glucose levels among people with Type 2 diabetes, by providing them with the same real-time recommendations for lifestyle decisions,  isual data and personal trends offered to people with Type 1 diabetes.

Type 2 diabetes represents a large market for Dexcom and its glucose monitors—including patients who are and are not receiving intensive insulin therapies—and serves as a main pillar of the company’s growth strategy for this year, Chairman, President and CEO Kevin Sayer said during the J.P. Morgan Healthcare Conference.

“Non-intensive Type 2 patients are a huge opportunity here in the U.S., with seven times more patients than there are in the intensive insulin space,” Sayer said. “And if you add to that prediabetes and diabetes prevention, the number of opportunities to serve patients in this market just becomes massive.”

“I'm frequently told by our team that when this market goes, it is going to explode—it's not going to be small, and it's not going to be slow,” he said. “There's often a perception that Type 2 patients don't want the same data a Type 1 patient wants. But if you look at our market research, absolutely the same percentage of patients wants to get into CGM and wants to use it.”

“I believe personally at the right price with the right solution, patients will use it all the time,” he added.

Sayer also described 2020 as the company’s best year ever, with total revenue up more than 30% over the prior year, to north of $1.925 billion. For 2021, Dexcom said it expects to see another 15% to 20% of growth, with sales totaling $2.21 billion to $2.31 billion. The company’s full financial results are expected February 11.

Looking ahead, 2021 will also be the year that Dexcom kicks the development of its next-generation CGM “into overdrive,” Sayer said. The new G7 sensor aims to be smaller and deliver an updated user interface and will be key to Dexcom’s plans to expand into additional international markets.

https://www.fiercebiotech.com/medtech/jpm-teladoc-to-pilot-cgms-type-2-diabetes-as-dexcom-eyes-new-growth-market

JPM: Steris snaps up infection prevention gear provider Cantel for $4.6B

 As the COVID-19 pandemic continues apace, Steris has moved to acquire Cantel Medical in a $4.6 billion deal for its portfolio of infection prevention products aimed at safeguarding endoscopic and dental procedures.

The cash and stock transaction comes in at $84.66 per share for Cantel, equivalent to its Jan. 11 closing price, amounting to about $3.6 billion in total equity value. The remaining $1 billion accounts for Cantel’s net debt and convertible notes. 

“The last year has demonstrated more than ever the importance of innovative and comprehensive infection prevention and control solutions that protect healthcare providers and patients,” Cantel CEO George Fotiades said in the companies’ announcement.

Cantel brought in about $1 billion in revenue over its 2020 fiscal year by selling disposables used in endoscopy procedures such as single-use valves and irrigation tubing, as well as scope reprocessing systems, disinfectants and detergents through its Medivators business division.

It also offers face masks, wipes, towels and bibs for dentists through its Crosstex International brand as well as water purification and equipment reprocessing systems for dialysis providers via Mar Cor Purification.

They will join Steris’ surgical and sterile processing equipment for operating rooms and ambulatory surgery centers—as well as equipment the company obtained through its recent acquisition of Key Medical, completed last November. 

“Together with Steris, we believe the value opportunity is compelling, both today and in a post-COVID world,” said Cantel’s chairman, Charles Diker, citing the combined company’s scale and range of product offerings.

Steris said it plans to fund the cash portion of the deal and repay a significant amount of Cantel’s existing debt, with about $2 billion of new debt and committed bridge financing. The deal is expected to close by the end of June.

https://www.fiercebiotech.com/medtech/jpm-steris-snaps-up-infection-prevention-gear-provider-cantel-medical-for-4-6b

JPM21: Tenet aims to acquire 25 to 40 surgical centers in 2021 in pivot from urgent care

 Tenet Healthcare plans to spend $150 million to acquire between 25 to 40 ambulatory surgery centers in 2021 as the hospital system continues its pivot to more higher acuity facilities and away from urgent care.

Tenet CEO Ronald Rittenmeyer detailed the 65-acute hospital system plan Tuesday during the annual J.P. Morgan healthcare conference, which is being held virtually this year.

At the end of the year, the system closed the acquisition of up to 45 ambulatory surgery centers to add to its subsidiary United Surgical Partners International (USPI), Rittenmeyer said. The acquisition grows USPI’s portfolio to as many as 310 ambulatory surgical facilities and 24 surgical hospitals.

Meanwhile, the sale of Tenet’s urgent care business “reflects a strategic move to rely on high-demand specialties,” Rittenmeyer said. “We don’t see urgent care business as important feeders to our hospitals.”

Tenet is expecting major growth from its ambulatory surgery business. The earnings before interest, taxes, depreciation and amortization (EBITDA) for ambulatory surgery is expected to grow from 4% in 2014 to 45% by the end of 2021, Rittenmeyer said.

The system is expected to grow its portfolio more in 2021. Rittenmeyer said they plan to spend $150 million to acquire 25-40 facilities and he expected annual same-store surgical revenue growth of more than 6%.

Tenet expects its surgery business to represent a larger share of the business over the next three years. It estimates USPI to increase its share of the company’s EBITDA portfolio mix to grow from 33% to 50% over the next three years and its hospital EBITDA mix to decline from 53% to 35%.

He added that USPI has a large portion of musculoskeletal services.

“It is growing more quickly in the ambulatory environment than the hospital environment,” Rittenmeyer said.

The pivot from urgent care centers to ambulatory surgery centers comes as the system is seeing much more high acuity or severe illness care due in part to the pandemic. Rittenmeyer speculated that the decline in lower acuity care is due to patients foregoing care due to hesitation from the pandemic.

https://www.fiercehealthcare.com/hospitals/tenet-aims-to-acquire-25-to-40-surgical-centers-2021-as-pivot-away-from-urgent-care

COVID vaccines 'a test of resilience' for anti-counterfeiting

 

Approval of COVID-19 vaccines are now coming swiftly, and the first candidates are now adminustered to the public in immunisation programmes across Europe, the US and other countries around the world.

Just this morning, Switzerland’s regulatory authority approved the Moderna vaccine, a few weeks after giving the go-ahead to Pfizer/BioNTech’s vaccine, under the brand name Comirnaty.

Both of these are regular marketing approvals, in contrast to the temporary or conditional supply permissions awarded by UK and EU regulators for the Moderna and Pfizer/BioNTech shots, and by the UK for AstraZeneca’s AZD1222 candidate.

These developments clearly mark the long-awaited turning point in the fight against this pandemic, even though the roll-out of vaccinations will need to gather significant pace.

More dark clouds on the horizon

There will be new battles ahead, as recent warnings by Interpol and Europol about the emerging threats of counterfeit vaccines show; the rush to bring the vaccine to patients as quickly as possible must not be at the cost of jeopardising the security of the medicines supply.

It could, of course, be argued that threats are negligible in Europe where the supply chain for regulated medicines is highly secure, in no small part thanks to the European Medicines Verification System (EMVS) that has been established to fulfil the requirements of the EU Falsified Medicines (EU-FMD) directive.

The EMVS provides a very high level of protection against counterfeiting (and other criminal activities) but – and this is an important ‘but’ – only if the products are supplied in compliance with the EU-FMD/EMVS processes.

All medicines supplied, including COVID vaccines, need to be serialised and tamper-evidenced. Additionally, their unique identifiers (UIs) must be recorded twice; once when the UIs are uploaded to the European Hub at the time of batch release, and again at the point of dispense, when every pack UI is checked against the appropriate National Medicines Verification System.

A good shot - but no silver bullet

There may be calls to bypass these additional hurdles in order to rush out the long-awaited vaccines as quickly as possible. This is understandable, and it is likely that temporary exemptions may be granted for the first batches of vaccines.

However, extending such exemptions beyond the initial batches would negate the full protection that the EU-FMD offers. It may be tempting to seek to avoid these obligations often portrayed as ‘onerous’ in the face of a novel and extraordinary situation, but this will ultimately deprive patients of the security that the EU-FMD and the EMVS system and processes have established.

It is reassuring to see that the labelling appendix to the product information for both the BioNTech/Pfizer and the Moderna vaccine specify the application of a 2D DataMatrix carrying the EU-FMD’s Unique Identifier (Annex IIIA, section 17) for the purpose of serialisation. AstraZeneca’s vaccine - authorised in the UK on 30th December 2020 - is also serialised, although the EU-FMD no longer applies to most of the UK (England, Scotland and Wales) after the UK’s exit from the European Union, and there is therefore no longer the facility for end-users in Great Britain to be connected to the EMVS - although the EU-FMD infrastructure and practice remains in place in Northern Ireland.

While the regular supply chain will offer a solid degree of protection for patients, it will - as always - be the most vulnerable part of the supply chain and population would be preyed upon by counterfeiters. This is why brand protection must be integrated as a key element in the commercialization of sensitive, and sadly less sensitive, products.

At the forefront of that battle, the Excellis brand protection team keep hammering this hard truth: hoping to be safe from counterfeiting is not a strategy. Recognising that the EU-FMD provides solid protection, there is no denying that the EMVS obligations will bring novel challenges for COVID vaccinations across Europe.

COVID vaccines will be dispensed in the course of a mass-vaccination programme, the likes of which has never been seen before. This means large numbers of products will be dispensed in a very short time, often in different locations, by different actors, using different protocols to regular medicines.

The EU-FMD has foreseen this, and there are provisions in the Delegated Regulation (Article 23) giving member states the scope to allow for medicines to be dispensed outside hospitals or pharmacies in non-routine supply scenarios. At the latest count, 11 EU member states have indicated they may want to make use of these provisions to be able to vaccinate as many people as possible, as quickly as possible.

EU alerts: a dark lining to the silver cloud

While this must be welcomed, we at Excellis are concerned that a perfect storm is going to hit the industry. A combination of new players, dispensing large numbers of products in non-standard scenarios and at locations where the scanning technology and processes have not yet been established as routine, is highly likely to generate a spike of EU-FMD alerts that manufactures need to deal with.

There is a real concern that many manufacturers are even today ill-prepared to deal with the routine number of EU-Alerts in timely manner and that they will be swamped by a flood of new alerts that are likely to arise due to technical issues, processing errors and – inevitably – human error. Ignoring these alerts, even if the vast majority are going to be false alerts, is not an option and manufacturers must ensure that their organisation and processes are ready to scale and flex up to this additional challenge they face once the vaccine roll-out begins in earnest.

https://www.securingindustry.com/pharmaceuticals/covid-vaccines-a-test-of-resilience-for-fmd-anti-counterfeiting/s40/a12767/

Aflac Expands Product Offerings with New Dental, Vision Plans

 Aflac, a leading provider of supplemental insurance products in the U.S., today announced the national launch of Aflac Dental and Vision Insurance, the company's expansion into offering products based on a provider network. As a component of the insurer's continual growth strategy, the new coverage allows Aflac to offer even more of the key benefits businesses desire to remain competitive and help attract and retain top talent.

U.S. employees cite dental insurance as the second most important benefit to them after health insurance, with vision insurance ranking their fourth most valued benefit after life insurance, according to the Aflac 2020-2021 WorkForces Report. Dental and vision plans not only help with costs associated with preventive health measures, but routine checkups and exams can lead to the detection of numerous conditions before they require more costly treatments. 

"With this national expansion into network dental and vision, Aflac is offering employers and consumers an expanded value proposition, while providing our associates and broker partners the tools they need to bring the most comprehensive set of products to a very competitive marketplace," said Aflac President of Group Benefits Rich Williams. "Combined with the incredible power of the Aflac brand, our new dental and vision plans will greatly enhance the trusted relationship we have built with employers and policyholders for nearly 70 years and offer prospective customers even more reason to consider Aflac's entire suite of products for their supplemental insurance solutions."

The new dental and vision coverage, available for businesses with as few as three employees in many locations, features a streamlined underwriting process, more than 100 easy-to-understand and fully customizable plans, and upfront rates.

https://www.prnewswire.com/news-releases/aflac-expands-product-offerings-with-new-dental-and-vision-insurance-301206417.html

JPM: Bio-Rad targets wastewater diagnostics opportunity

 Bio-Rad's executives told the virtual audience during its presentation at the conference that the coming year will see the Hercules, California-based firm taking advantage of a projected $200 million opportunity in molecular surveillance of wastewater using digital PCR, and expanding into the single cell sample preparation market for sequencing with its Celsee acquisition.

Meanwhile, it will also grow its Asia Pacific business and further develop its growing bioprocessing and pharmaceutical support business.

CFO Ilan Daskal also said that though Bio-Rad has previously preferred making two to three tuck-in acquisitions each year, Bio-Rad is ready for a larger, transformative deal, ranging from a $1 billion to $2 billion transaction "up to a merger of equals [depending on] what opportunity will arise."

For such a transaction to happen, one must wait for the right opportunity and react quickly, he said, adding that "we are very open-minded ... but we want to entertain a transaction with a unicorn."

Additionally, on the capital deployment front, Bio-Rad will continue to be opportunistic about share buybacks, he added.

Bio-Rad expects $235 million in COVID-19-related sales in 2021, skewing toward its PCR instrumentation business. Chief Operating Officer Andy Last said its open-platform instruments were placed in small- and medium-sized labs globally and can potentially be redirected as needed when the pandemic ultimately abates.

Bio-Rad's only COVID-19 test to date, the Bio-Rad SARS-CoV-2 ddPCR Kit, runs on its droplet digital PCR system and was granted Emergency Use Authorization from the US Food and Drug Administration in May. Although Bio-Rad is "clearly a late mover" in the SARS-CoV-2 RT-qPCR diagnostic assay space, Last said it now expects EUA decisions imminently for two other assays.

These include "one syndromic test and one straight COVID-19 PCR test," Last said, likely referring to singleplex and multiplex RT-qPCR assays for SARS-CoV-2 and influenza. Bio-Rad also expects EUA for a neutralizing antibody test on its BioPlex automated multiplex immunoassay system. For the PCR assays, Bio-Rad will pursue selling them for use with its instrument installed base, but the tests can also be run on any open RT-qPCR platform, Last said.

Company officials said that the firm's droplet digital PCR business continued to grow at double digits through the pandemic, and Bio-Rad sees it as a long-term growth driver with broad applications. A new digital PCR entry from Qiagen, the QiAquity, does not change Bio-Rad's outlook, Last said, but rather is a "testament to the importance of digital PCR to the broader market."

Bio-Rad CEO Norman Schwartz said that Bio-Rad anticipates sustained COVID-19 testing demand well into 2021, but beyond that it is unclear. "We're in a little bit of a new world here," he said.

https://www.genomeweb.com/business-news/jp-morgan-healthcare-conference-2021-day-one-roche-seer-10x-guardant-hologic-thermo#.X_37sehKjIU